This study is not being conducted in the United States. Patients who are intolerant of topical corticosteroids (TCS) have either experienced an adverse event resulting from the use of TCS, or require unacceptable levels of exposure to TCS in order to control their AD. This is of particular concern for patients with recurrent flares on delicate skin areas such as the head and neck. The purpose of this study is to investigate whether pimecrolimus cream 1%, a non-steroidal anti-inflammatory drug, is efficacious in treating mild to moderate head and neck AD in patients who are intolerant of, or dependent on topical corticosteroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Pimecrolimus Cream 1 %
Vehicle cream (placebo cream)
This study is not being conducted in the United States
Novartis Pharma AG, Switzerland
The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
Percentage of responders in overall Eczema Area and Severity Index (EASI) score
Percentage of responders in the head and neck EASI score
Percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
Percentage of patients achieving a score of 0 or 1 for the pruritus score (absent or mild)
Effects on skin atrophy and telangiectasia (spider veins) existing at baseline
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